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Clinical Trials/NCT01622452
NCT01622452
Unknown
Not Applicable

Neurocognitive Deficits Related to Cardiac Surgery Intervention With Extracorporeal Circulation. Correlations Between Neuropsychological Tests and Functional MRI Techniques (Spectroscopy, Diffusion and Morphometry)

Fondazione Toscana Gabriele Monasterio0 sites50 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Cognitive Dysfunction
Sponsor
Fondazione Toscana Gabriele Monasterio
Enrollment
50
Primary Endpoint
Brain MRI microstructural/functional alteration due to cardiac surgery in association with POCD
Last Updated
12 years ago

Overview

Brief Summary

Postoperative cognitive decline (POCD) is a frequent complication after cardiac surgery. It is estimated that 40-70% of all cardiac patients show cognitive dysfunction during the first post-surgical week. Six weeks after surgery, this incidence decreases to 10-40% and the figure remains stable over the long-term.

The investigators will recruit 50 patients undergoing elective valve surgery and each patient will receive complete evaluation a) preoperative, one week before surgery; b) early postoperative, before hospital discharge; and c) late postoperative, 8 weeks follow up.

The investigators will apply Diffusion Tensor Imaging, 1Proton-Magnetic Resonance Spectroscopy and Morphometry studies with correlation to neuropsychological test battery to evaluate POCD.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
October 2016
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Montanaro Domenico

Responsible of the Neuroradiological Unit, Foundation CNR - Regione Toscana G. Monasterio

Fondazione Toscana Gabriele Monasterio

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing elective valve surgery in Ospedale del Cuore, Fondazione G. Monasterio, Massa, Italy will prospectively enter the study.

Exclusion Criteria

  • History of head trauma, seizures, stroke, carotid artery stenosis (\>70%)
  • History of any major surgery with general anesthesia
  • Preoperative MMSE score less than 23 to exclude patients with dementia and mild cognitive impairment (MCI)
  • Subjects who will be unable to complete the baseline neuropsychological battery due to cognitive impairment, psychiatric disease, substance abuse, blindness, or poor knowledge of Italian language
  • Any major neurological complication after CABG surgery (stroke, seizures, encephalopathy not resolving within few postoperative days)
  • if any contraindications to MRI safety, indicated in local MRI safety protocol

Outcomes

Primary Outcomes

Brain MRI microstructural/functional alteration due to cardiac surgery in association with POCD

Time Frame: 32 months

On the basis of scientific literature, the patients during the first post-cardiosurgical week can show cognitive dysfunction in 40-70% of the cases, decreasing after 6 weeks to 10-40%, remaining stable over the long-term. To identify corresponding brain specific microstructural variations, simultaneously to the neuropsychological evaluation, the same group of patients will undergo to MRI with standard sequence and advanced morpho-structural methods (DTI and VBM). Comparing data with a group of healthy age-matched subjects (20), quantitative measurements by VBM and DTI will be carried out to identify GM and WM variations, subsequently correlated with onset of POCD.

Brain MRI metabolic alteration due to cardiac surgery in association with POCD

Time Frame: 32 months

To explore pre- and post- operative metabolic changes on the brain using in-vivo proton magnetic resonance spectroscopy (1H-MRS) after otherwise successful cardiac surgery with no major neurological event.

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